Clinical Research Regulatory Coordinator II (Hybrid)

University of Alabama at Birmingham; Birmingham (AL); Hybrid; USD 48,000 - 62,000; Full time

Job summary

The University of Alabama at Birmingham (UAB) seeks a Clinical Research Regulatory Coordinator II to oversee regulatory documentation and IRB submissions. The role requires strong knowledge of federal regulations, HIPAA, and informed consent processes, with experience in regulatory binders and eISFs.

Responsibilities include preparing submissions, maintaining documentation, and coordinating with sponsors and investigators to ensure compliance across studies.

Qualifications

• Bachelor's degree required.
• Minimum 3 years of related regulatory experience.
• Knowledge of ICH-GCP, FDA, OHRP, and HIPAA.
• Familiarity with informed consent processes and regulatory binders.

Responsibilities

• Prepare, submit, and track IRB applications and amendments.
• Maintain regulatory documentation and licensure records.
• Draft informed consents and assist with FDA IND/IDE submissions.
• Support sponsor visits, audits, and inspections.
• Monitor regulatory compliance and QA audits.
• Use electronic databases for regulatory operations.
• Perform other duties as assigned.

Skills

IRB submissions

Regulatory compliance

Documentation management

Education

Bachelor's degree

Tools

MURE

IRAP

Veeva Vault

Florence e-binder

Job description

The University of Alabama at Birmingham (UAB) seeks a Clinical Research Regulatory Coordinator II to oversee regulatory documentation and IRB submissions. The role requires strong knowledge of federal regulations, HIPAA, and informed consent processes, with experience in regulatory binders and eISFs.

Responsibilities include preparing submissions, maintaining documentation, and coordinating with sponsors and investigators to ensure compliance across studies.